Hoping you can help with a couple of research points to support content development related to rapid testing in pharmacies for f

Part
01
of four
Part
01

RapidFlu/Strep Diagnosis

Retail pharmacies in the US that currently offer rapid flu/strep diagnosis include Meijer, CVS, Walgreens, Rite Aid, Publix pharmacies, Magnolia Pharmacy, and Rx Clinic Pharmacy.

RAPID FLU/STREP DIAGNOSIS

  • Walgreens conducts A & B rapid flu testing and releases the results in 15 minutes.
  • CVS Pharmacy offers rapid flu and strep test through physician assistants at its MinuteClinic locations.
  • RediClinic, Rite Aid's pharmacy service, offers instant diagnosis for five ailments including flu and strep.

FLU ANTIVIRAL PRESCRIPTION AGREEMENTS

  • Kroger pharmacy was involved in collaborative practice agreement (CPA) training for Salt Lake City area pharmacies to prescribe flu antiviral medications, but it is not clear whether Kroger has secured the agreement.
  • Rx Clinic Pharmacy has a procedure where they call the prescriber of Tamiflu for the treatment of flu after a positive test result and request for a prescription to be sent by phone or fax where they do not have collaborative practice agreements.

RESEARCH STRATEGY

To find retail pharmacies in the US that currently offer rapid flu or strep diagnosis, we started by looking publicly available lists of such retail pharmacies. But we did not find any list of retail pharmacies in the US that currently offer rapid flu or strep diagnosis. We then conducted an extensive search through the public domain for retail pharmacies in the US that currently offer rapid flu or strep diagnosis. Through this strategy, we were able to find different retail pharmacies that offer such diagnosis.

Although optional, we proceeded to search for retail pharmacies in the US that having agreements in which they can prescribe flu antiviral medications Tamiflu or Xofluza. We only found examples of community and government-owned pharmacies like WesternU PCC Pharmacy with such agreements.

We also found a Collaborative Drug Therapy Agreement (CDTA) developed by Washington State Pharmacy Association, and Public Health - Seattle & King County for use by local health officers, authorized prescribers, and pharmacists to prescribe flu medications in Washington State. But there is no information on the individual pharmacies that are using the agreement or if the medications included Tamiflu or Xofluza.
Part
02
of four
Part
02

Back to School Flu/Strep Statistics

Statistics related to the spread of flu/strep during the back-to-school season suggest that strep usually occurs most commonly among children who are between the ages of five and 15. Among the commonly-known risk factors that increase the chance of a person getting serious complications from the flu are usually asthma, blood disorders, and a weakened immune system

STATISTICS RELATED TO THE SPREAD OF FLU/STREP DURING THE BACK-TO-SCHOOL SEASON

  • The national baseline in the US for flu infection is 2.2%, with flu being defined as a fever with a temperature of 100°F [37.8°C] or greater, accompanied with coughs and/or a sore throat, commonly known as influenza-like illness (ILI).
  • Group A strep pharyngitis (strep throat) usually occurs most commonly among children ages 5-15.
  • During week 32, ending August 11, 2018, of the Influenza Season, 0.7% of visits of patients due to ILI was reported by the US Outpatient Influenza-like Illness Surveillance Network (ILINet).
  • According to estimates by medical experts, group A strep, which is the most commonly identified bacterial cause of infection, causes between 20% to 30% of episodes of pharyngitis in children.
  • There was one case of influenza-associated pediatric death reported by the CDC during week 34 of the 2017-2018 Influenza Season, with week 34 ending August 25, 2018 (back-to-school season).
  • The risk factors that significantly increase the chances of spreading strep infection include conditions such as crowding, which is a common occurrence for example in schools, military barracks, and daycare centers.
  • Among the commonly-known risk factors that increase the chance of a person getting serious complications from the flu are asthma, neurodevelopment and neurologic conditions, blood disorders such as sickle cell disease, and a weakened immune system.
  • The northern areas of the United States are regional areas that are slightly more affected by strep throat even as much as the infection is experienced throughout the nation as well.
  • Treating a person who is affected by strep with an antibiotic for at least 24 hours or longer generally helps eliminate the threat they pose in spreading the bacteria even further. Therefore, it is usually recommended that people with strep stay home from work, school, or daycare, up to such a time when they are afebrile and at least 24 hours have elapsed since they began the appropriate antibiotic therapy.
Part
03
of four
Part
03

BD Veritor Plus Market Share

While no publicly available information exist for the market share of BD Veritor Plus for group A strep and flu testing, we have used the available data to pool together some helpful findings. Our research revealed that greater technology has lead to increased accuracy and savings in the influenza diagnostic market, which in turn is increasing the demand for diagnostic products. We have included in the strategy section our research methodology to help explain the unavailability of information.

HELPFUL FINDINGS

  • Greater technology has lead to increased accuracy and savings in the influenza diagnostic market, which in turn is increasing the demand for diagnostic products.
  • A paid report on global influenza diagnostic trends could be reviewed to gain an insight into the overall global trend, which is expected to compound annually with a growth rate of 6.4%.
  • While this paid report is on the global strep testing market, the report will go into detail specific to the US and industry leaders.
  • A paid report on the global influenza market not only lists the growth trends for the market, but also information on industry leaders, including their supplier and marketing information.
  • Additional paid reports show the key vendors in the global rapid influenza diagnostic tests market, as well as their drivers and challenges.

Research Strategy

The first research approach was a direct analysis approach to find any relevant sources displaying the actual market share of the BD Veritor Plus system. We searched industry and market publications and any articles for the market share for Becton, Dickinson and Company (BD). Websites like Grand Research Review showed global market trends for the diagnostic market, but none for specific products in the United States. Statistical websites like Statista.com were searched, but no information could be found on this specific topic. All direct searches did not yield any relevant information for revenue or market share.

Since no data was found from the direct approach, research was conducted to determine if BD displays this financial information in any of their SEC Filings. In this triangulation approach, the revenue for BD Veritor Plus would have been compared to the revenue of its competitors of influenza and group A strep diagnostic products. The 2018 Annual Report lists the revenue of the company's organizational units and does not list revenue information for individual products. The BD Veritor Plus system falls under the Diagnostic Systems Unit of the Life Sciences' segment. The latest 2019 Quarterly Report also lists the revenue per organizational unit and not for individual products. This information is likely not made public due to the proprietary nature of these figures. In addition, the revenue information of its competitors products were also not available.

We conducted additional research for the quantity of units of BD Veritor Plus system sold. If the total quantity of sold units were known, additional research into an average selling price could yield an estimate for the total revenue of the product and this could then be compared to their competitors' products to arrive at a total market value. However, research into the same industry and market publications and any articles yielded no information. Once again, this is likely due to the proprietary nature of this information.



Part
04
of four
Part
04

Top Group A strep and Flu Testing Products

Some of the group A strep and flu testing products are BD Veritor Plus system, Cobas® Liat System-Roche, and Abbott’s Influenza A & B 2 and Strep A 2 molecular assays.

BD Veritor Plus

  • BD Veritor Plus is an immunoassay test for diagnosis of influenza A and B, respiratory syncytial virus (RSV), and group A strep used in hospitals, clinics, physician offices to get the results within minutes.
  • In 2017, BD Veritor Plus System received approval for testing influenza A7B and strep A by modifying the previous BD Veritor System Flu A+B test which was approved in 2011.
  • The annual report of Becton Dickinson & Co. does not provide details on its sales and market share.

Cobas® Liat System-Roche

  • Cobas Liat PCR system is a polymerase chain reaction (PCR) technology test for the diagnosis of influenza A and B, Cdiff, respiratory syncytial virus (RSV), and group A strep. The results are produced within 15 minutes for a Strep A diagnosis and 20 minutes for an Influenza A/B diagnosis.
  • In 2018, Roche sold more than 1500 Cobas Liat PCR systems in the US.
  • Roche Diagnostics had revenue of CHF 2.91 billion (USD2,231,857,398.77) in 2018 but did not detail on Cobas Liat PCR system sales.
  • Roche's annual report states that Cobas Liat has high demand in North America and EMEA but did not quote any supporting revenue figures specific to the United States.

Abbott’s Influenza A & B 2 and Strep A 2 Molecular Assays

  • Abbott received FDA approval for Influenza A & B 2 and Strep A 2 molecular assays in October 2018.
  • Alere Scarborough, Inc. received FDA approval for Influenza and Respiratory Viruses.
  • Influenza A & B, Strep A, RSV testing kit, and Alere is acquired by Abbott.

Additional Insights

  • Companies such as Cephid have testing products for flu as well as Strep A. However, they do not have an integrated product which is capable of diagnosing both.
  • Key players in Streptococci testing market are Roche Diagnostics, Novartis Diagnostics, Ortho Clinical Diagnostics, Sigma Aldrich, Abbott Diagnostics, Beckman Coulter, bioMerieux, DiaSorin, Hologic, Qiagen, and Thermo Fischer Scientific.
  • Key players in Influenza diagnostic market include Becton, Dickinson and Company, Roche Diagnostics, Thermo Fisher Scientific, Alere, and Quidel Corporation.

YOUR RESEARCH TEAM APPLIED THE FOLLOWING STRATEGY:

Information on the top three group A strep and flu testing products in the US based on market share is not available because there are no details on sales or market share. This group A strep and flu testing market is very niche and not well-established. Due to lack of sufficient data, we were also unable to triangulate the information and rank the products.

Initially, we searched for the information on various US diagnostics market reports and media releases such as Prnewswire, Markets and Markets, Grandviewresearch, Market Watch, and other similar sites with a motto to derive market share details to determine the top three products. We gathered that most of the information is specific to either influenza testing market or Streptococcus market but not both.

Subsequently, we identified all the key players (Roche Diagnostics, Novartis Diagnostics, Ortho Clinical Diagnostics, Sigma Aldrich, Abbott Diagnostics, Beckman Coulter, bioMerieux, DiaSorin, Hologic, Qiagen, Thermo Fischer Scientific) in both the markets. Further, we tried to find data on product releases and sales of group A strep and flu testing products with an intention that companies in either one of these markets will more likely focus on their product upgrades. We examined their websites, annual reports, and other publication. We located that Abbott, Roche, and Becton Dickinson & Co launched products which diagnose both group A strep and Influenza. And, companies such as Cephid have testing products for both flu and strep A but not an integrated one which could diagnose both. Later, we tried to check the above-mentioned products' market share and sales but the details are very limited in the public domain to rank them as the top.

We expanded the scope of our search across the globe and beyond the time frame of 24 months. We searched various global diagnostic reports, regulatory authorities, diagnostic research journal articles, US diagnostics and medical device databases with an aim to gather details on the US sales from global companies. And, get a glimpse on group A strep and flu testing products in websites such as CDC, USFDA, NCBI, EPPO, VYaire, Siemens, imvinfo, among others. Based on the results, we concluded that group A strep and flu testing products are very limited worldwide and are still in their budding phase.
We also performed a search on the websites of reputed diagnostics in the US to find information on company collaborations of group A strep and flu testing products. However, we couldn't trace one. Quest, Sonic Healthcare, Foundation Medicine, and Response Genetics are some of the sources we looked into.
Sources
Sources

From Part 02
Quotes
  • "Group A strep pharyngitis can occur in people of all ages. It is most common among children 5 through 15 years of age"
  • "Experts estimate that group A strep, the most common bacterial cause, causes 20% to 30% of pharyngitis episodes in children."
  • "Treating an infected person with an antibiotic for 24 hours or longer generally eliminates their ability to transmit the bacteria. Thus, people with group A strep pharyngitis should stay home from work, school, or daycare until: They are afebrile and at least 24 hours after starting appropriate antibiotic therapy"
  • "Crowding, such as found in schools, military barracks, and daycare centers, increases the risk of disease spread"
From Part 04
Quotes
  • "Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has cleared its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing1,2. These new assays enable the fastest-ever3 time to molecular influenza A & B and Strep A results at the point of care."
  • "4 Currently available on the ID NOW™ platform (formerly Alere i), both assays have been granted a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver. "
Quotes
  • " The now Class II BD Veritor System Flu A+B test became available in 2011, and is the same test used on the new BD Veritor Plus System, a next generation wireless rapid diagnostic system for detection of influenza A and B, respiratory syncytial virus (RSV) and group A strep."
Quotes
  • "We have in excess of 1,500 systems placed in the US, largely respiratory panels, and we continue to expand on that menu," he added. The firm noted in its presentation that the Liat is sold to hospitals, emergency rooms, physician offices, health clinics, and retail pharmacies. Globally, year-over-year sales grew 262 percent."
  • "In diagnostics, Roche reported revenues of CHF 2.91 billion, up from CHF 2.77 billion in 2017."
Quotes
  • "About the size of a single-serve coffee maker, the cobas® Liat® PCR System delivers rapid, reliable results when they’re needed most, including turnaround times of ~15 minutes for a Strep A result, 20 minutes for an Influenza A/B, Influenza A/B & RSV, or Cdiff result."
Quotes
  • " Some of the key players in the influenza diagnostic market consist ofRoche Diagnostics, Becton, Dickinson and Company, Thermo Fisher Scientific, Alere, and Quidel Corporation"
Quotes
  • "Continued high demand was reported for cobas Liat tests, the new system for molecular point-of-care testing. Regional growth was led by EMEA and North America."